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CTRI Number  CTRI/2017/07/008957 [Registered on: 03/07/2017] Trial Registered Prospectively
Last Modified On: 03/07/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   To evaluate a new technique of drainage of bile ducts when conventional endoscopy fails 
Scientific Title of Study   A Prospective evaluation of preoperative biliary drainage using Endoscopic ultrasound guided hepato-gastrectomy in distal malignant biliary obstruction 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinay Dhir 
Designation  Consultant Gastroenterologist  
Affiliation  Global Hospital, Mumbai 
Address  Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9819920266  
Fax    
Email  vinaydhir@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vinay Dhir 
Designation  Consultant Gastroenterologist  
Affiliation  Global Hospital, Mumbai 
Address  Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9819920266  
Fax    
Email  vinaydhir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vinay Dhir 
Designation  Consultant Gastroenterologist  
Affiliation  Global Hospital, Mumbai 
Address  Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400012
India 
Phone  9819920266  
Fax    
Email  vinaydhir@gmail.com  
 
Source of Monetary or Material Support  
Endoscopy research foundation,3rd floor, Global Hospital, Ernest Borges Road, Mumbai 400012 
 
Primary Sponsor  
Name  Endoscopy Research foundation 
Address  Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
VINAY DHIR  Global Hospital  Room 301/302, Department of Gastroenterology,Baldota Institute of Digestive Sciences, Global Hospital, Ernest Borges Road, Mumbai
Mumbai (Suburban)
MAHARASHTRA 
9819920266

vinaydhir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Global Hospital, Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Distal biliary obstruction with obstructive jaundice,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Partially covered self expandable metal stent  These are stents designed for endo luminal use which can be deployed under EUS guidance with standard technique of similar well documented EUS guided interventions. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1 Willing and able to comply with the study procedures and provide written informed consent to participate in the study
2 Diagnosis of probable pancreatic cancer, distal common bile duct (CBD) cholangiocarcinoma and ampullary cancers
3 Biliary obstructive symptoms or signs
4 Bilirubin level > 2 mg/dl
5 Patients deemed as resectable by pancreatic protocol CT or MRI
6 Surgery intent within 4 weeks
 
 
ExclusionCriteria 
Details  1 Biliary strictures caused by confirmed benign tumors
2 Biliary strictures caused by malignancies other than pancreatic cancer, distal CBD cholangiocarcinoma and ampullary cancers.
3 Hilar stricture or obstruction due to any cause.
4 Neoadjuvant chemotherapy for current malignancy
5 Palliative indication due to reasons other than surgical candidate status
6 Previous biliary drainage by ERCP/PTC
7 Patients for whom endoscopic techniques are contraindicated
8 Participation in another investigational trial within 180 days
9 Pregnancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the technical & clinical success and immediate complications of preoperative biliary drainage by EUS-HGS in patients with distal malignant biliary obstruction  2, 4, 6, 8 weeks follow up 
 
Secondary Outcome  
Outcome  TimePoints 
After EUS-HGS in postoperative period (after surgery) to study
1 Length of hospital stay after surgery
2 Biliary obstruction symptoms assessment (Jaundice and prurutis)
 
4 weeks 
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Preoperative biliary drainage in distal malignant biliary obstruction is considered to decrease jaundice prior to delayed curative surgery. Present rationale is biliary drainage using ERCP and biliary stenting. Some studies favours direct surgery rather than preoperative drainage, but have certain limitations. Biliary stenting can be done either with plastic or covered metal stent. However, covered metal stents have added advantages such as decrease risk of bleeding, pancreatitis, frequent stent block prior to surgery and are retrievable.

EUS-guided biliary drainage (EUS-BD) is an established alternative technique to unsuccessful endoscopic retrograde cholangio-pancreaticography (ERCP) in patients with malignant biliary obstruction.  Recent study establishes the short term outcome and complications comparable between EUS-BD and ERCP. In addition complication like pancreatitis was frequent in ERCP than EUS-BD.   Among different methods of EUS guided biliary drainage, EUS guided hepatogastric stenting  (EUS-HGS) showed more technical and clinical success with comparable complication rate. EUS-HGS has certain advantages over conventional biliary drainage. Firstly challenging step of antigrade guidewire passage both in rendezveous & antegrade stenting is avoided. Secondly, it is more physiological in patients with altered anatomy (congenital or altered) as it requires less repeated puncture.

 


 
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